NCT01651819

Brief Summary

Urological physical therapy is described to improve urinary symptoms in patients with myelopathy or neurological dysfunction and to increase the quality of life. Although it was never tested on HTLV-1 associated overactive bladder syndrome, an disabling disease that is common seen in HAM/TSP patients but can also appear as an isolated form. Our hypothesis is that urological physical therapy can improve urinary symptoms like incontinence, urgency and nocturia in HTLV-1 infected population with those complains.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2015

Completed
Last Updated

October 5, 2018

Status Verified

October 1, 2018

Enrollment Period

2.8 years

First QC Date

July 25, 2012

Last Update Submit

October 3, 2018

Conditions

Tropical Spastic ParaparesisHTLV-1

Keywords

HTLV-1neurogenic bladderphysical therapyTropical Spastic Paraparesis

Outcome Measures

Primary Outcomes (1)

  • Reduction in urinary symptoms

    reduce or cure the complaints of urinary symptoms measured by daily and nocturnal frequency, presence of incontinence, urgency, dysuria.

    6 months

Secondary Outcomes (1)

  • Improve in quality of life

    6 months

Study Arms (1)

Urological physical therapy

EXPERIMENTAL

Urologic physical therapy is going to be apply in 20 patients with HTLV-1 infection and overactive bladder symptoms like urgency, incontinence and nocturia. There will be 20 sessions with one hour duration and a interval of 3 or 4 days between the sections.

Procedure: Urological physical therapy

Interventions

Urological physical therapyPROCEDURE

Individual patient attending with one hour duration beginning with Behavior therapy and education, teaching urinary maneuvers, water adequate intake. Second part is manual therapy an Kinesiotherapy with specific exercises, followed by patient repetition. Last part is constituted by electrotherapy for specific muscle stimulation and biofeedback.

Also known as: Electrotherapy;, Behavior therapy;, Manual therapy;, Kinesiotherapy.
Urological physical therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with HTLV-1 with more than 18 years and neurogenic bladder defined by urodynamic study.

You may not qualify if:

  • Diabetes Mellitus,
  • Stroke,
  • Multiple Sclerosis,
  • Parkinson disease,
  • use of pacemaker,
  • urinary infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitário Prof. Edgard Santos

Salvador, Estado de Bahia, Brazil

Location

MeSH Terms

Conditions

Paraparesis, Tropical SpasticUrinary Bladder, Neurogenic

Interventions

Electric Stimulation TherapyBehavior TherapyMusculoskeletal Manipulations

Condition Hierarchy (Ancestors)

MyelitisCentral Nervous System InfectionsInfectionsHTLV-I InfectionsDeltaretrovirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeurologic ManifestationsUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitationPsychotherapyBehavioral Disciplines and ActivitiesComplementary Therapies

Study Officials

  • Rosana Andrade, Master

    Federal University of Bahia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
coordenadora do Ambulatório de Fisioterapia Nas Disfunções perineias

Study Record Dates

First Submitted

July 25, 2012

First Posted

July 27, 2012

Study Start

March 1, 2012

Primary Completion

December 30, 2014

Study Completion

July 30, 2015

Last Updated

October 5, 2018

Record last verified: 2018-10

Locations

BR(1)